Bayer HealthCare has obtained approval from the US Food and Drug Administration (FDA) for its Finacea (azelaic acid) Foam, 15% to treat inflammatory papules and pustules of mild to moderate rosacea.
Papulopustular rosacea is a skin disease, which causes inflammatory lesions (papules and pustules) on the nose, cheeks, chin and forehead.
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Bayer HealthCare consumer care division innovation, research and development head Dr John O’Mullane said: "With the FDA’s approval of Finacea Foam, we can now offer patients suffering from rosacea in the US a new treatment option.
"This demonstrates Bayer’s continued commitment to delivering innovation that meets the preferences and needs of patients with mild to moderate rosacea."
Approval was based on results of two pivotal clinical trials that demonstrated the efficacy and safety of Finacea Foam compared against foam vehicle (without the drug azelaic acid) in the topical treatment of papulopustular rosacea.
The two multicentre, double-blind and vehicle-controlled clinical trials randomised the subjects in a 1:1 ratio to receive either azelaic acid foam, 15% or its foam vehicle twice-daily for 12 weeks.
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By GlobalDataSafety and tolerability have been assessed during the full 16-week study course, while the efficacy endpoints were evaluated at the end of the 12-week treatment period.
In the two studies, treatment with Finacea Foam resulted in a higher investigator’s global assessment (IGA) success rate compared with vehicle control, as well as greater reduction in the mean nominal change of inflammatory lesion count from baseline to the end of the 12-week treatment period, said the company.
The company plans to provide Finacea Foam through prescription in the US from the next month.
Image: Acne rosacea on face. Photo: courtesy of RicHard-59.
